Pilot Trial of HER-2/Neu Pulsed DC1 Vaccine for Patients With HER-2 Positive Metastatic Cancer

We have demonstrated that administration of HER-2/neu pulsed DC1 in patients with DCIS
results in strong immunologic responses as well as clinical responses during a brief 4 or 6
week neoadjuvant vaccination. In subsets of patients with cancer HER-2 is over-expressed
including subsets of breast, gastric, pancreatic, brain, lung, and colon cancer. This trial
is designed for compassionate use of a HER-2/neu pulsed DC1 in patients with metastatic
HER-2 positive cancer, who have no longer standard options to eliminate disease.

Inclusion Criteria:

1. Age ≥ 18 years.

2. Subjects with active metastatic HER-2 positive cancer, at least 1+ by IHC, that have
already received standard therapy who have exhausted other treatment options.

3. Subjects with HER-2 1+ need to be HLA 2 or HLA A3 positive. There are no HLA
restrictions for HER-2 2+ or 3+.

4. Women of childbearing age with a negative pregnancy test documented prior to
enrollment.

5. Subjects with ECOG Performance Status Score of 0 or 1 (Appendix D).

6. Women of childbearing potential must agree to use a medically acceptable form of
birth control (medically accepted methods: birth control pills, condoms and
spermicidal lubricants, intrauterine device, and diaphragm) during their
participation in the study.

7. Subjects who have voluntarily signed a written Informed Consent in accordance with
institutional policies after its contents have been fully explained to them.

Exclusion Criteria:

1. Pregnant or lactating females.

2. Subjects with positive HIV or hepatitis C at baseline by self report.

3. Subjects with coagulopathies, including thrombocytopenia with platelet count <75,000,
INR > 1.5 and partial thromboplastin time > 50 sec

4. Subjects with major cardiac illness MUGA or ECHO < 50% EF.

5. Subjects with pre-existing medical illnesses or medications which might interfere
with the study as determined by PI.

6. Subjects receiving current therapy that may suppress immune system, such as steroids,
chemotherapy at the discretion of the PI.